Drug developers are taking proactive measures to address the “formidable” challenges of securing the right comparators for clinical trials at the right time, in the right quantities, and at the right price, says the US-based Tufts Center for the Study of Drug Development (TUFTS CSDD).
The Center recently convened a roundtable discussion among leaders from the research-based pharmaceutical industry on new strategies to improve companies’ access to, and use of, comparator drugs.
According to Tufts CSDD director Kenneth Kaitin, a lack of “fully robust” supply-chain management practices, coupled with a growing emphasis on expensive biologics, changing regulatory requirements and the growth of counterfeit medicines, is forcing trial sponsors to “rethink and redesign their comparator-drug supply chains to support drug development that, increasingly, crosses international borders”.
Despite the hurdles, Kaitin added, industry is making headway with pro-active approaches such as improving communication between internal R&D and commercial operations, or willingness to sell commercially available products to other drug developers.
Investing in supply chain
Most importantly, he noted, clinical-trial sponsors are investing in their comparator supply chains to bolster in-house capabilities, while also aligning with external service providers.
Among key points that arose during the industry roundtable were:
- Up to half of industry’s clinical-supply budget is spent on comparators, although there are large variations in expenditure between companies.
- Planning, sourcing, logistics management and pricing need to be in balance if the right quantity of comparator products is to be available when and where it is needed.
- The share of clinical studies using centrally and locally sourced comparators differs by region, with local sourcing calling for additional oversight to manage multiple-country requests for the same product.
The next scheduled Tufts CSDD Executive Forum Roundtable is on 20 February 2014, under the title ‘Predictors of Clinical Success: New Approaches to Boosting Success Rates’.